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FDA 510(k)

PNEUPAC PARAPAC PLUS

K-Number: K123957 · 2013-09-16

ApplicantSmiths Medical International , Ltd.
Decision Date2013-09-16
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PNEUPAC PARAPAC PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical International , Ltd.. It received FDA 510(k) clearance on 2013-09-16 under 510(k) number K123957. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PNEUPAC PARAPAC PLUS?

PNEUPAC PARAPAC PLUS is a medical device that received FDA 510(k) clearance on 2013-09-16. The listed applicant is Smiths Medical International , Ltd.. The 510(k) number is K123957.

When did PNEUPAC PARAPAC PLUS receive FDA 510(k) clearance?

PNEUPAC PARAPAC PLUS received FDA 510(k) clearance on 2013-09-16, under 510(k) number K123957.

Who is the listed applicant for PNEUPAC PARAPAC PLUS?

The FDA 510(k) record lists Smiths Medical International , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PNEUPAC PARAPAC PLUS?

The FDA product code for PNEUPAC PARAPAC PLUS is BTL.

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Other records listing Smiths Medical International , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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